U.S. Department of Energy’s Consolidated Laboratory Auditing and Proficiency Testing Programs George E. Detsis Manager, Analytical Services Program Office of Corporate Safety Analysis, HS-30 Presented before the 2009 Department of Defense Environmental Monitoring and Data Quality Workshop March 30 – April 3, 2009 San Antonio, Texas

Presentation Outline Mission Statement Auditing Background Audit Checklists Laboratory Audit Findings Laboratory Audit Schedule FY09 Proficiency Testing Background Proficiency Testing Accomplishments

Program Mission To foster development of quality environmental data of known and documented value; thereby, improving the confidence level of decision-makers, enhancing public trust, and reducing inherit agency liabilities.

DOECAP Background Program Purpose: Program Implementation: Elimination of audit redundancies Standardization of audit methodology, policies and procedures Communication of Lessons Learned Reduction of overall Department risks and liabilities Program Implementation: Administrative funding by DOE-HSS Headquarters through the Analytical Services Program Linked to Site and Contractor laboratory contractual agreements Involves participation by all DOE line and field organizations Auditors are primarily DOE contractors Auditors are trained and qualified Federal DOE staff supplement laboratory audit staff

Audit Findings Priority I Finding: Priority II Finding: Observation: Key programmatic/systematic failure Imminent threat to worker or public safety/health Documented unlawful or unethical practices Significant data quality failures Failure to implement corrective actions/repeat deficiencies Priority II Finding: Nonconformance with internal requirements/procedures Undocumented procedures or processes Nonconformance with DOE requirements Observation: Isolated instance or minor deficiency Opportunity for improvement

Audit Checklists DOECAP Laboratory Checklists Module 1 - Quality Assurance Management Systems and General Laboratory Practices Module 2 - Data Quality for Organic Analyses Module 3 - Data Quality for Inorganic and Wet Chemistry Analyses Module 4 - Data Quality for Radiochemistry Analyses Module 5 - Laboratory Information Management Systems and Electronic Data Management Module 6 - Hazardous and Radioactive Materials Management

Laboratory Findings by Audit Discipline

Findings and Observations/ Laboratory Over Past Nine Fiscal Years

Laboratory and Commercial Waste Vendor Contractual Agreements Projected FY09 DOECAP Audited Facilities Utilized by Each DOE Site

Common Laboratory Findings QA Management Systems and General Laboratory Practices A lack of SOPs or inadequate SOP content, particularly in sub-sampling and support equipment maintenance. QAP deficiencies including a lack of direction for internal assessments, certification documentation, major equipment documentation, etc. Inadequate or untimely closure of corrective actions. A lack of logbook review, with incomplete or inconsistent implementation of corrections. Lack of back-up systems to prevent catastrophic loss of samples (i.e., monitoring refrigerators on a calendar day basis). Inadequate control of log books, notebooks, or operational aids. Failure to notify clients of accreditation loss or Performance Testing failures.

Common Laboratory Findings Data Quality for Organic Analyses All target analytes are not included in matrix spikes or laboratory control samples over a two year period. Calibration deficiencies. Data Quality for Inorganic and Wet Chemistry Analyses SOPs do not reflect actual practices being implemented in the lab. Failure to utilize a solid matrix for laboratory control samples during analysis of soil and other solid matrices. Consecutive Performance Test failures in soil matrices.

Common Laboratory Findings Data Quality for Radiochemistry Analyses Consecutive Performance Test failures in soil matrices. Inadequate documentation and references for gamma and alpha spectroscopy instrument libraries. Methods and/or practices do not include all required Programmatic QC elements. Laboratory Information Management Systems and Electronic Data Management Lack of computer hardware/software security measures (e.g., controlled server access, unprotected spreadsheet formulas for calculating data). Inadequate inspections and testing of software and electronic data. An absence of SOPs and system documentation.

Common Laboratory Findings Hazardous and Radioactive Materials Management Deficiencies in sample receipt of potentially radiological materials. Inadequate tracking and documentation of unused sample portions to disposal or return to client.

FY09 Laboratory Audit Schedule Laboratory Proposed Month Laboratory Proposed Month S&ME, Inc October 2008 Paragon March 2009 Assaigai October 2008 SwRI April 2009 Test America, Knoxville November 2008 GEL April 2009 GPL , Maryland December 2008 EMAX April 2009 USEC Paducah December 2008 BC Laboratories May 2009 ORISE, Oak Ridge January 2009 USEC Portsmouth May 2009 Eberline Oak Ridge January 2009 Shaw May 2009 BWXT Lynchburg February 2009 Test America, Richland June 2009 UTB RMAL February 2009 Davis and Floyd June 2009 Eberline Richmond February 2009 Caltest June 2009 Xenco February 2009 CEBAM June 2009 MCL March 2009 Test America, Arvada July 2009 Lionville March 2009 Shealy Environmental July 2009 GPL , Alabama March 2009 DataChem SLC July 2009 Test America, St. Louis March 2009 ARS July 2009 * Highlighted Laboratories are both DOE/DOD Audited Laboratories

MAPEP Background Program Purpose: Program Focus: To test and evaluate environmental analytical laboratory performance. To provide defensible data that instills confidence in DOE decision-making. Program Focus: ISO 17025 Accredited PT Provider with traceability to NIST Radiological, stable inorganic, and organic analyses. Soil, water, air filter, and vegetation media. Interaction with DOECAP and QSAS. - MAPEP required for all laboratories performing analysis for DOE

MAPEP Laboratories MAPEP Laboratory Participants: 109 Domestic Laboratories 17 International Laboratories - Nuclear Test Ban Treaty Laboratories New Zealand (1); Brazil (1) - Cooperative Monitoring Canada (2); United Kingdom (2) - Middle Eastern Nations Jordan (3); Irag (1); Oman (1); Kuwait (1); Qatar (1); Turkey(1); Morocco (1); Israel (1) - International Atomic Energy Agency (1)

MAPEP Accomplishments DOE’s - Radiological and Environmental Sciences Laboratory (RESL) on the Idaho National Laboratory, Idaho Falls, Idaho ISO 17025 Accredited Proficiency Test Provider (American Association for Laboratory Accreditation (A2LA) approval on a 2 year cycle) RESL won A-76 Study competition for outsourcing Letter of Obligation – formalizes work commitments (3 yrs./2 option years) MOU – NE/HSS/RESL defines roles/responsibilities

MAPEP Initiatives Test session 20 distribution (March 2009) Test session 21 distribution (September 2009) 60 day timeframe for laboratory reporting test results to RESL New remedial PT sample policy – one remedial attempt, then must also pass subsequent routine PT session HSS Letters of Concern for consecutive PT failures Track and trend reasons for Letters of Concern

Proficiency Testing Analyses Samples Distributed to Participating Laboratories, MAPEP Series 19 (2008) MAPEP Matrix Series 19 Matrix Id. Total Samples Foreign Labs Mixed-Analyte Soil MaS 113 16 Mixed-Analyte Water MaW 133 17 Semi-volatile Organic Water OrW 38 Radiological Vegetation RdV 70 15 Radiological Air Filters RdF 87 13 Gross alpha/beta Water GrW 72 11 Gross alpha/beta Filter GrF 75 8 Increase in Samples Distributed and Analyses by Laboratories Fiscal Year Series Number of MAPEP Samples # of Analyses by Laboratories FY07 15 & 16 1098 13628 FY08 17 & 18 1136 13605 FY09 19 & 20 1200 14000

Laboratory Auditing and Proficiency Test Preparation

Radiological Analysis Liquid Scintillation Counting

2009 ASP Workshop Date: September 13-17, 2009 Location: Snow King Lodge Jackson Hole, Wyoming

ASP Program Contact Information George E. Detsis, Analytical Services Program (ASP) Manager Phone: (301) 903-1488 E-mail:  George.Detsis@hq.doe.gov Jorge Ferrer - DOECAP Manager, DOE Oak Ridge Phone: (865) 576-6638 E-mail:  ferrerja@oro.doe.gov Guy Marlette, MAPEP Coordinator, Idaho National Laboratory Phone: (208) 526-2532 E-mail: marletgm@id.doe.gov Brent Pulsifer, VSP Coordinator, Pacific Northwest National Laboratory Phone: (509) 375-3989 E-mail: Brent.Pulsipher@pnl.gov